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TKA: No benefit of spray-application PRP for wound healing, pain, and function
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May 2013
TKA: No benefit of spray-application PRP for wound healing, pain, and function
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
No positive effect of autologous platelet gel after total knee arthroplasty
Acta Orthop. 2009 Oct;80(5):557-62. doi: 10.3109/17453670903350081Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
102 patients scheduled for total knee arthroplasty due to osteoarthritis of the knee were randomized to determine the efficacy of autologous blood platelet concentrate on wound healing following surgery. Patients were allocated to receive a spray application of platelet-rich plasma (PRP) to the wound site prior to closure or to a control group receiving no PRP application. Follow-up was conducted for up to 3 months post-operatively for outcomes of wound healing, pain, and function. Wound healing at 2 weeks was found to be significantly better in the control group, with a higher proportion of control patients achieving total closure. Patients who received PRP also displayed no benefits in regards to pain and function.
Publication Funding Details
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Funding:
Industry funded
Sponsor:
Biomet, Dordrecht, the Netherlands
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Accelerated wound healing following total knee arthroplasty (TKA) is beneficial, allowing for the possibility of greater functional outcomes. Accordingly, there has been recent interest in researching methods to enhance healing following surgery, which has brought popularity to platelet concentrates and related products. The high concentration of growth factors sourced from platelets has been reported to enhance tissue repair and bone formation in a number of interventions. However, high quality clinical investigations to demonstrate efficacy of autologous blood platelet concentrate in TKA are still required.
What was the principal research question?
In adult patients undergoing TKA, what is the effect of autologous blood platelet concentrate on wound healing, knee function, and analgesic requirement at 3 month follow-up?
Study Characteristics
-
Population:
102 patients who underwent primary unilateral TKA for osteoarthritis of the knee. The medial parapatellar approach was used in all cases, with a cemented posterior cruciate-retaining prosthesis.
Intervention:
PRP group: Prior to wound closure, patients were treated with a spray application of autologous blood platelet concentrate with the knee flexed at 90 degrees. Platelet-rich plasma (PRP) was prepared using the GPS System (Biomet). 53mL of the patient's blood was collected in a 60mL syringe containing 7mL of citrate phopshate dextrose anticoagulant. Mixture was centrifuged at 3200rpm for 15 minutes, obtaining approximately 6mL of platelet-rich plasma fraction. The platelet-poor fraction (approximately 10mL) was also spray-applied to the subcutaneous tissues after the clousre of the joint capsule. (n=50; 32 included in analysis))
Comparison:
Control group: Patients did not receive additional PRP intervention with TKA procedure. (n=52; 41 included in analysis)
Outcomes:
A wound score form was used to assess wound healing, ranging from 0-100 (0 representing a dry wound without signs of infection, 100 representing wound leakage with signs of infection). A 100-mm visual analog score (VAS) was used to evaluate pain at rest and during walking, and function was assessed through both range of motion (ROM) evaluation and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Hemoglobin levels and postoperative analgesic usage were also recorded.
Methods:
RCT, Double-blind
Time:
Follow-up was conducted on postoperative days (POD) 3-5, 6 weeks, and 12 weeks.
What were the important findings?
- Wound closure during hospitalization did not significantly differ between the two groups (POD3: P=0.5, 95%CI 7% (-11% to 25%); POD4: P=0.4, 95%CI 9% (-30% to 10%)).
- By two weeks post-operatively, the number of patients with total wound closure was significantly greater in the control group (16/46) compared to the PRP group (4/36) (P=0.02, 95%CI -24% (-41% to 7%)).
- Pain reduction at 6 weeks approached significance favoring the control group (At rest: P=0.08; During walking: P=0.07). However, difference in pain between groups diminished at 3-month follow-up (At rest: P=0.8; During walking: P=0.9).
- Frequency of pain medication use was similar between groups at both 6-week (P=0.9) and 3-month (P=0.1) follow-up evaluations.
- Functional outcomes did not significantly differ between groups: ROM evaluation (In hospital (POD 2-4): P=0.7; 3 months: P=0.9), and WOMAC score (6 weeks: P=0.7; 3 months: P=0.4).
What should I remember most?
Spray application of platelet-rich plasma for total knee arthroplasty was not associated with any benefit in wound healing. Additionally, there was no beneficial effect of platelet-rich plasma treatment on pain, analgesia or functional outcome over 3-months.
How will this affect the care of my patients?
The findings of this study do not support the use of spray-applied autologous blood platelet concentrate in total knee arthroplasty due to the lack of efficacy in improving wound healing, pain, and function compared to control. Since there was significant loss of power to detect differences between groups as a result of the integration of two hospitals into one and the subsequent loss of data, results of this research should be considered only as indicative rather than conclusive.
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